Clinical Trial Labeling

Labeling an Investigative New Drug (IND) / Investigative Medical Product (IMP) or an Investigative Medical Device for clinical trials is a complex process requiring well-documented procedures and careful oversight. Required label information can vary based on whether it is an open or blind trial, the phase of the trial and where the clinical trial is located. For pharmaceutical companies and Contract Research Organizations (CRO), this can be a time-consuming and labor-intensive process requiring frequent updates throughout the trial process.

Loftware’s solutions ease the management of required label content and translations while helping you meet requirements for Good Manufacturing Processes (GMP), such as the EU’s Annex VI and FDA’s 21 CFR Part 211. Labeling errors can delay trials, waste product or even invalidate results, potentially costing millions. Accuracy of label content, auditability of procedures and traceability of the drug throughout the trial are critical.

Loftware offers solutions to help manage the challenges of clinical trial labeling, improving accuracy and traceability, reducing waste and shortening time-to-market.